The following data is part of a premarket notification filed by Litecure, Llc with the FDA for Bwf-5 Medical Laser Series.
| Device ID | K123031 |
| 510k Number | K123031 |
| Device Name: | BWF-5 MEDICAL LASER SERIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LITECURE, LLC 250 Corporate Blvd. Suite B Newark, DE 19702 |
| Contact | Liang Lu |
| Correspondent | Liang Lu LITECURE, LLC 250 Corporate Blvd. Suite B Newark, DE 19702 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-12-03 |